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Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome

NCT02390362 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-03-26

Study results available
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Summary

We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than MMF in maintaining remission in children with frequent relapsing or steroid dependent nephrotic syndrome who have had one relapse while receiving MMF.

We will conduct a randomized study comparing two Rituximab infusions and continued MMF treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).

Conditions

  • Frequent Relapsing Nephrotic Syndrome
  • Steroid Dependent Nephrotic Syndrome

Interventions

DRUG

Rituximab

We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF

DRUG

MMF

Subjects randomized to MMF, will continue MMF as scheduled by the investigator

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • The NephCure Foundation

    collaborator OTHER

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • William Smoyer, MD · The Research Institute at Nationwide Children's Hospital

  • Laurence Greenbaum, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-07
Completion
2017-01-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390362 on ClinicalTrials.gov